760033
H & H Medical — FEI 3003339833
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 10, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Williamsburg, VA (United States)
Citations
| ID | CFR | Description |
|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 4228 | 21 CFR 821.25(a) | Written tracking program |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |